CGM - Reimagine Primary Care

NCT04413578 | Completed Phase 4 FDA Device

• 1 other identifier: 1050955
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 4

Brief Summary

To assess the impact of continuous glucose monitoring versus standard of care (e.g. a finger-prick protocol using a glucometer) on clinical outcomes, healthcare utilization, and cost in patients with type I or II diabetes treated within the Reimagine Primary Care clinics.

Conditions

Diabetes Mellitus, Type 2

Keywords

Continuous Glucose Monitor (CGM); Dexcom G6

Outcome Measures

Primary Outcomes (2)

• HbA1c Variation

  Coefficient of variation in HbA1c levels before, during and end of study completion.

  6 months

• HbA1c Range

  Variation of range in HbA1c levels before, during and end of study completion.

  6 months

Secondary Outcomes (7)

• Current Diabetes Standards

  6 months

• Behavioral Changes

  6 months

• Hypoglycemic Events

  6 months

• Healthcare Utilization

  6 months

• Glycemic Variability

  6 months

Study Arms (2)

Dexcom G6 (Intervention Group)

EXPERIMENTAL

• Intervention group: CGM using a Dexcom G6 to measure glycosylated hemoglobin levels every five minutes. Patients will be asked to download the Dexcom G6 and Clarity applications (to have access to their real-time data) and be given a link to complete an exit survey in REDCap near the end of their study participation. Data will be sent via Bluetooth and then exported by the Intermountain research team into a Tableau (or similar) dashboard for data analysis/comparison

Device: Dexcom G6

Contour NextOne (Standard of Care) Glucometer

PLACEBO COMPARATOR

• Control group: A standard finger-prick protocol that will require patients to continue with their daily fingerprick regimen established by their physician. This group will be given a Contour Next One meter to ensure that each patient is receiving the same level of accuracy by the same device. A review by Ekhlaspour et al of 17 glucose meters demonstrated wide variability, with only two devices achieving the 2013 ISO standard (with the most accurate being the Contour Next). Patients in the control group will be asked to download the Contour Next application which will send data via Bluetooth similar to above. Data will be aggregated, and protected health information removed prior to analysis (by Intermountain Healthcare and Savvysherpa). At the end of the study, patients will be asked to complete a short survey in REDCap about their willingness to participate in future studies.

Device: Contour NextOne

Interventions

Dexcom G6 DEVICE

Continuous Glucose Monitor that, after applied, sends continuous glucose readings to to the patient's smartphone every 5 minutes. This allows the patients to receive more readings over a 24 hour period versus standard of care glucometer finger sticks.

Dexcom G6 (Intervention Group)

Contour NextOne DEVICE

A Standard of Care Glucometer with Bluetooth capability. The patient inserts a test strip into the device, takes a finger stick and collects a small blood sample on the tip of the strip to initiate the device to detect a glucose reading.

Contour NextOne (Standard of Care) Glucometer

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 1 or type 2 diabetes mellitus with a HbA1c ≥6.5%
• Patients that are currently managing their glucose levels for diabetes with a glucose meter (or will be prescribed one by their healthcare provider)
• Patients that are treated within the four Reimagine Primary Care clinics (Cottonwood Family Medicine, Cottonwood Senior, Avenues Internal Medicine, and Holladay Internal Medicine). • Patients 18-80 years of age

You may not qualify if:

• Patients that are not managing their glucose levels for diabetes (and not advised to use a glucose monitor by their physician)
• Patients that are not treated within the four Reimagine Primary Care clinics
• Patients less than 18 years of age, and 81 years of age and older
• Patients with a diagnosis of dementia
• If the patient is currently using a Continuous Glucose Monitor
• Patients with previous hospitalization for hypoglycemia within the last 18 months
• No access to a mobile phone to download the Dexcom or Contour Next applications
• Patients who are pregnant or planning to become pregnant over the course of their six-month participation

Sponsors & Collaborators

• Intermountain Health Care, Inc.: lead

Study Sites (4)

Holladay Internal Medicine

Holladay, Utah, 84121, United States

Location

Intermountain Cottonwood Family Practice

Murray, Utah, 84107, United States

Location

Intermountain Senior Clinic

Murray, Utah, 84107, United States

Location

Avenues Internal Medicine

Salt Lake City, Utah, 84103, United States

Location

Related Publications (6)

• Lee PA, Greenfield G, Pappas Y. The impact of telehealth remote patient monitoring on glycemic control in type 2 diabetes: a systematic review and meta-analysis of systematic reviews of randomised controlled trials. BMC Health Serv Res. 2018 Jun 26;18(1):495. doi: 10.1186/s12913-018-3274-8.

  PMID: 29940936 RESULT

• Medical Advisory Secretariat. Home telemonitoring for type 2 diabetes: an evidence-based analysis. Ont Health Technol Assess Ser. 2009;9(24):1-38. Epub 2009 Oct 1.

  PMID: 23074529 RESULT

• Ekhlaspour L, Mondesir D, Lautsch N, Balliro C, Hillard M, Magyar K, Radocchia LG, Esmaeili A, Sinha M, Russell SJ. Comparative Accuracy of 17 Point-of-Care Glucose Meters. J Diabetes Sci Technol. 2017 May;11(3):558-566. doi: 10.1177/1932296816672237. Epub 2016 Oct 3.

  PMID: 27697848 RESULT

• Verkuilen J. Explanatory Item Response Models: A Generalized Linear and Nonlinear Approach by P. de Boeck and M. Wilson and Generalized Latent Variable Modeling: Multilevel, Longitudinal and Structural Equation Models by A. Skrondal and S. Rabe-Hesketh. Psychometrika. 2006 Jun;71(2):415-418. doi: 10.1007/s11336-005-1333-7. No abstract available.

  PMID: 28197954 RESULT

• Fong Y, Rue H, Wakefield J. Bayesian inference for generalized linear mixed models. Biostatistics. 2010 Jul;11(3):397-412. doi: 10.1093/biostatistics/kxp053. Epub 2009 Dec 4.

  PMID: 19966070 RESULT

• Musio M, Sauleau EA, Augustin NH. Resources allocation in healthcare for cancer: a case study using generalised additive mixed models. Geospat Health. 2012 Nov;7(1):83-9. doi: 10.4081/gh.2012.107.

  PMID: 23242683 RESULT

Related Links

• What is Diabetes
• Diabetes and glucose information

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Patients were either randomized to the Dexcom G6 Device or the Contour NextOne a Standard of Care glucometer. Both subjects knew what they received after they were randomized.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Randomized Control Trial

Study Record Dates

• First Submitted: May 21, 2020
• First Posted: June 4, 2020
• Study Start: December 1, 2018
• Primary Completion: November 28, 2019
• Study Completion: December 31, 2019
• Last Updated: June 4, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)